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July 17, 2019
FDA sent a warning letter to Ecometics, Inc. after the agency found CGMP violations at the company’s Norwalk facility.
The draft guidance describes how content should be organized in electronic submissions for all submission types under section 745A(a) of the FD&C Act.
July 12, 2019
Slovakia becomes the final European Union country to be recognized by FDA, and the mutual recognition agreement for inspections of manufacturing sites between the US and the EU is now fully implemented.
July 11, 2019
The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.
July 10, 2019
The FDA guidance defines changes to approved risk evaluation and mitigation strategies and clarifies submission guidelines.
The draft guidance provides industry with a guide for using the database to assist in the development of drug products.
FDA released draft guidance on using the USP pending monograph process in the drug application process.
July 03, 2019
FDA sent warning letters detailing violations of current good manufacturing practices to three companies that repack APIs.
July 02, 2019
New guidance documents clarify production standards and processes for developing interchangeable biologic drugs.
FDA proposes rule to help ensure availability of hormones and enzymes formerly classified as drugs, and to stimulate biosimilars competition.